Edwards Lifesciences Receives FDA Approval To Add Transapical Delivery System To U.S. Clinical Trial Of Transcatheter ... (Medical News Today)
Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, announced that it has received conditional approval from the U.S. Food and Drug Administration (FDA) for a revised design to the U.S. pivotal clinical trial of the Edwards SAPIEN transcatheter aortic heart valve technology.

FDA Cannot Meet Requirements For Inspections Of Medical Device Manufacturing Facilities, GAO Report Finds (Medical News Today)
FDA cannot meet requirements for inspections of medical device manufacturing facilities in the U.S. and abroad, according to a Government Accountability Office report scheduled for release on Tuesday at a hearing of the House Energy and Commerce Oversight and Investigations Subcommittee, the Wall Street Journal reports (Wilde Mathews, Wall Street Journal, 1/29).

Researchers Query FDA About Updating Requirements for Drug Approval (Newswise)
Scientists and the Food and Drug Administration (FDA) are discussing how new technologies in ophthalmology, which make it possible to collect better data about experimental treatments, might affect FDA clinical trials requirements.